Relieva Luma Sentry
Relieva Luma Sentry Sinus Illumination System, 1 PK
1manufacturer
2catalogue numbers in this listing
8510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Shanghai.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
Record
| Listed by | Acclarent, Inc., United States |
|---|---|
| FDA product code | KAM |
| Device type | Cannula, Sinus |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K071845 |
| Record published | 2016-10-01 |
| Record revised | 2025-07-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in a cool, dry place |
| Packaging | Box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SIS100BZ | In distribution | |
| SIS100B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Osseous | EON Meditech PVT. Ltd. | 46 |
| Frazier suction tube | Spiggle & Theis Medizintechnik Gmbh | 28 |
| Bear | Bear-ENT, LLC | 25 |
| Eicken antrum cannula | Spiggle & Theis Medizintechnik Gmbh | 19 |
| Medline | Medline Industries, Inc. | 17 |
| Jedmed | Jedmed Instrument Company | 11 |
| Osseous Suction tubes for Nose Reusable | EON Meditech PVT. Ltd. | 10 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 10 |
| Relieva Flex | Acclarent, Inc. | 8 |
| Instrumentarium | Société Chirurgicale Instrumentarium Inc | 7 |
| Integra® | Integra LifeSciences Production Corporation | 6 |
| Inka | The Trustee for Kaiser Family Trust | 4 |
Showing 12 of 59. All products under Cannula, Sinus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K110687 | 2011-10-07 |
| K093594 | 2010-03-03 |
| K083574 | 2009-01-29 |
| K072891 | 2008-03-19 |
| K073041 | 2008-03-11 |
| K071845 | 2007-09-28 |
| K062458 | 2006-09-15 |
| K060974 | 2006-05-05 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-04-28 | Class III | Nonconforming Material/Component | Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it’s expiry date. | 986 | 2015-06-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.